For Thursday, January 31st
ORCC, ABIO, AMHD, NHYT, PCFGD, KERX
Our Stocks to Watch today include Online Resources Corp. (Nasdaq: ORCC), ARCA biopharma Inc. (Nasdaq: ABIO), Amelot Holdings Inc. (OTC: AMHD), Neohydro Technologies Corp. (OTCBB: NHYT), Pacific Gold Corp. (OTCBB: PCFGD) and Keryx Biopharmaceuticals Inc. (Nasdaq: KERX).
ONLINE RESOURCES CORPORATION (NASDAQ: ORCC)
"Up 81.43% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/ORCC.php
Online Resources (ORCC) powers financial interactions between millions of consumers and the company's financial institution and biller clients. Backed by its proprietary payments gateway that links banks directly with billers, Online Resources provides web and phone-based financial services, electronic payments and marketing services to drive consumer adoption. Founded in 1989, Online Resources is the largest financial technology provider dedicated to the online channel.
ORCC News:
January 30 - ACI Worldwide to Strengthen Leadership in Online Banking and Payments with Acquisition of Online Resources
Adds new payment and presentment solutions while enhancing commitment to online banking
ACI Worldwide (Nasdaq: ACIW), a leading international provider of payment systems, and Online Resources (Nasdaq: ORCC), a leading provider of online banking and full-service bill pay solutions, today announced that they have entered into a definitive transaction agreement. Under the terms of the agreement, ACI Worldwide will acquire Online Resources in an all cash transaction for $3.85 per share. The boards of directors of both companies have approved the transaction. ACI Worldwide will hold a conference call on January 31, 2013, at 8:30 a.m. EST to discuss this information.
The integration of ACI Worldwide and Online Resources will make available to financial institutions the preeminent online and mobile banking, bill payment and presentment solutions. ACI Worldwide is recognized as the leader in the U.S. Large Bank Market for 2012 and a Company to Watch in 2013 by Aite Group. The addition of Online Resources’ payment and presentment capabilities will benefit customers by giving them the choice and flexibility to address a broader set of needs from a single integrated source.
The acquisition would also broaden ACI Worldwide’s customer base with the addition of 1,000 banks, credit unions, billers, credit card issuers, and other credit and payment service providers.
“Built on our heritage of producing highly reliable and trusted solutions, ACI Worldwide’s mission is to deliver universal payment solutions that provide control, choice and flexibility to our customers while maintaining their peace of mind,” said Philip Heasley, President and CEO of ACI Worldwide. “Online Resources’ robust product set and talented employee base of online banking and payment experts is well-aligned with this focus and our desire to lead in a category undergoing accelerating change.”
“I believe the combination of the two companies will allow the Online Resources product suite to now achieve its full potential in the Banking and Biller Markets, provide even better services and functionality for our clients and customers, and create additional opportunity for our dedicated and hardworking employees,” said Joe L. Cowan, President and Chief Executive Officer of Online Resources.
Online Resources is a leading provider of hosted online banking and bill payment solutions, providing its services to over 1,000 financial institutions and billers. The company processes over 245 million bill payment transactions annually. Backed by its proprietary payments engine, Online Resources’ bill payment solutions connect over 9,000 billers.
The acquisition strengthens ACI Worldwide’s leadership in the online channel with the addition of complementary online banking and full-service bill payment solutions for financial institutions and billers. The pro forma financial implications of the transaction are compelling. ACI Worldwide anticipates that with Online Resources it will achieve annual cost synergies of approximately $19.5 million. The transaction is expected to be accretive to full year non-GAAP earnings in 2013.
For the last twelve months ending September 30, 2012, the companies combined generated pro forma revenue of approximately $860 million and adjusted EBITDA of $182 million. The acquisition is being financed with a new $300 million Incremental Term Loan. ACI Worldwide has received fully committed financing for the transaction from Wells Fargo Bank, N.A.
Terms of the Transaction
ACI Worldwide and Online Resources have entered into a definitive transaction agreement under which ACI Worldwide would acquire Online Resources for $3.85 per share in cash in a transaction valued at an enterprise value of approximately $263 million, which includes the redemption of Online Resources’ preferred stock. ACI Worldwide will commence a cash tender offer to purchase all outstanding shares of common stock of Online Resources no later than February 15, 2013.
Upon the successful closing of the tender offer, stockholders of Online Resources will receive $3.85 per share in cash for each share of Online Resources common stock validly tendered and not validly withdrawn in the offer, without interest and less any applicable withholding taxes. ACI Worldwide will file with the U.S. Securities and Exchange Commission (SEC) a tender offer statement on Schedule TO which sets forth in detail the terms of the tender offer. Additionally, Online Resources will file with the SEC a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of Online Resources’ board of directors that Online Resources stockholders accept the tender offer and tender their shares.
The tender offer will expire at 12:00 midnight New York City time, twenty business days after the tender is launched unless extended in accordance with the transaction agreement and the applicable rules and regulations of the SEC.
Offering materials will be available on the SEC’s website at www.sec.gov. Online Resources stockholders are urged to read the offering materials filed by ACI Worldwide, as well as materials filed by Online Resources relating to the tender offer, which contain important information about the tender offer.
Timing
The closing of the tender offer is subject to customary terms and conditions, and is anticipated to close at the end of first quarter of 2013.
Advisors
Wells Fargo Securities is serving as financial advisor to ACI Worldwide, and Jones Day is serving as its legal advisor. Raymond James & Associates Inc. is serving as financial advisor to Online Resources, SunTrust Robinson Humphrey, Inc. provided certain financial advice to the Special Committee of the Board of Directors, and Morris, Manning & Martin, LLP is serving as its legal advisor.
ABOUT ACI WORLDWIDE
ACI Worldwide (ACIW) powers electronic payments and banking for more than 1,650 financial institutions, retailers and processors around the world. ACI Worldwide software enables $12 trillion in payments each day, processing transactions for 14 of the leading global retailers, and 24 of the world’s 25 largest banks. Through our integrated suite of software products and hosted services, we deliver a broad range of solutions for payments processing, card and merchant management, online banking, mobile, branch and voice banking, fraud detection, and trade finance.
ARCA BIOPHARMA INCORPORATED (NASDAQ: ABIO)
"Up 36.15% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/ABIO.php
ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company's lead product candidate, Gencaro™ (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention trea™ent. ARCA has a collaboration with the Laboratory Corporation of America (LabCorp), under which LabCorp has developed a companion genetic test for Gencaro.
ABIO News:
January 30 - New Adaptive Phase 3 Trial Planned for Gencaro™ in Atrial Fibrillation
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation, heart failure and other cardiovascular diseases, provided an update on a proposed, genetically-targeted clinical trial in atrial fibrillation (“AF”) of the Company’s lead developmental drug, Gencaro (bucindolol hydrochloride). The Company also announced that Medtronic, Inc., a leader in medical technologies to improve the treatment of chronic diseases, including cardiac rhythm disorders, has signed a non-binding Letter of Intent to collaborate on the initial, Phase 2B portion of the proposed trial.
The Proposed GENETIC-AF Phase 3 Adaptive Design Clinical Trial
The trial, known as GENETIC-AF, is projected to be a 620-patient, Phase 3 study comparing Gencaro to metoprolol CR/XL for prevention of AF in patients with heart failure and left ventricular dysfunction ("HFREF"). The Trial is planned to be genetically enriched by enrolling only those patients who possess the cardiac beta-1 adrenergic receptor genotype 389 arginine homozygous, which in the Beta Blocker Evaluation of Survival Trial ("BEST") was associated with an enhanced response to Gencaro in preventing atrial fibrillation. The Company estimates that this genotype is present in about 50% of the U.S. population. The primary endpoint of GENETIC-AF is planned to be the combination endpoint of recurrent symptomatic AF and all-cause mortality, over 24 weeks post electrical cardioversion for persistent AF. Commencement of the GENETIC-AF is conditional on receipt of the necessary funding, which ARCA intends to secure through equity financing or a strategic partnership.
ARCA has created an adaptive design for GENETIC-AF, under which the Company plans to initiate a Phase 2B study in approximately 200 HFREF patients. Depending on the results of the Phase 2B portion, the trial could then be expanded to a Phase 3 study by enrolling an estimated additional 420 patients. A secondary endpoint of the proposed Phase 2B portion of the trial will be AF burden, defined as a patient’s actual time in AF, regardless of symptoms. Under the Company’s proposed design, all 200 patients in the Phase 2B portion of the trial will have AF burden measured by continuous monitoring, either by previously implanted cardiac resynchronization or defibrillation devices, or newly or previously inserted implantable loop recorders. At the end of enrollment of the first 200 patients, the primary endpoint of recurrent symptomatic AF and all-cause mortality, and the secondary endpoint of AF burden will be evaluated by the trial’s Data and Safety Monitoring Board for evidence of an efficacy signal. If a sufficient efficacy signal is detected and acceptable safety is observed, the trial would then proceed to the Phase 3 portion and full enrollment.
ARCA believes that Gencaro has potential as a treatment for AF, based on placebo-controlled data from the Phase 3 heart failure BEST study. A retrospective analysis of data from the BEST Trial shows that patients with the genotype that ARCA plans to enroll in GENETIC-AF had a 74% reduction in the risk of AF compared to placebo (p = 0.0003). These same patients experienced a 38% reduction in the risk of all cause mortality (p < 0.05) and statistically significant improvements on other major clinical efficacy endpoints.
AF is considered an epidemic cardiovascular disease with an estimated prevalence of at least 2.7 million Americans in 2010. In HFREF patients, the approved therapies for the treatment or prevention of AF have disadvantages, such as toxic or cardiovascular adverse effects, and most of the approved drugs are contra-indicated or have warnings in their prescribing information. ARCA believes there is an unmet medical need for new AF treatments that are safe and more effective in the HFREF population at risk for AF.
ARCA has received guidance from the Food and Drug administration (“FDA”) regarding a Phase 3 clinical study comparing Gencaro to metoprolol for the prevention of AF in approximately 600 HFREF patients, with a design similar to GENETIC-AF, but without an adaptive feature. Based on this FDA guidance, the Company believes that a successful Phase 3 clinical study similar to GENETIC-AF, with a p-value of less than 0.01, could be sufficient evidence of efficacy upon which to base a New Drug Application (“NDA”) for the approval of Gencaro for an AF indication in HFREF patients. ARCA plans to obtain further guidance from the FDA, which may affect the trial’s design.
The proposed collaboration with Medtronic involves a substudy of the Phase 2B portion of GENETIC-AF that will measure the AF burden data by means of the continuous monitoring devices. Under the proposed collaboration, Medtronic would provide support associated with the AF burden substudy and with collection and analysis of the substudy data.
Dr. Michael Bristow, MD, PhD., President and Chief Executive Officer of ARCA, said, “We at ARCA are excited about the new adaptive design for GENETIC-AF and the potential to use AF burden measured by previously implanted devices as well as by newly inserted implantable loop recorders, which we believe represent the next generation of diagnosis and treatment options for patients at risk for AF. AF is a serious disorder that increases the risk of stroke and mortality, and in HFREF patients often heralds the worsening of heart failure. There is a need for new treatment options, particularly for patients with HFREF. The GENETIC-AF trial has the potential to result in an approvable new therapy that is safe and effective for HFREF patients at high risk for AF. We believe that the use of continuous monitoring devices including implantable loop recorders to monitor AF burden in the Phase 2B substudy will result in many more clinically-relevant events, which will potentially increase the power and usefulness of the data. We believe that AF burden used in conjunction with drug therapy will become an increasingly important tool in the diagnosis and treatment of AF.”
AMELOT HOLDINGS INCORPORATED (OTC: AMHD)
"Up 100.00% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/AMHD.php
Amelot Holdings, Inc. (www.amelotholdings.com), a publicly traded company, is a diversified holding company that has identified Biodiesel as a $20 billion emerging market. Amelot plans to have a significant market share in growing low cost feedstocks to supply the growing demand for biodiesel, to reduce energy dependency of fossil fuels, to help reduce the U.S. dependency on foreign oil supplies and reduce the impact of energy on our environment.
AMHD News:
No recent news for Amelot Holdings, Inc. (OTC: AMHD).
NEOHYDRO TECHNOLOGIES CORPORATION (OTCBB: NHYT)
"Up 400.00% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/NHYT.php
Neohydro Technologies Corp. does not have significant operations. The company intends to seek a company or companies that it can acquire or merge with. Previously, it was engaged in the business of installing patented turbo systems that were proven to assist an engine in its operation in the light and heavy-duty trucking industry. The company was formerly known as Rioridge Resources Corp. and changed its name to Neohydro Technologies Corp. in July 2008. Neohydro Technologies Corp. was founded in 2007 and is based in El Paso, Texas.
NHYT News:
No recent news for Neohydro Technologies Corp. (OTCBB: NHYT).
PACIFIC GOLD CORPORATION (OTCBB: PCFGD)
"Up 44.93% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/PCFGD.php
Pacific Gold Corp. engages in the identification, acquisition, exploration, and development of mining prospects primarily in the United States. The company, through its subsidiaries, owns claims, property, and leases in Nevada, Oregon, and Colorado. Its property portfolio comprises 68 placer and lode mining claims, including the Black Rock Canyon Mine covering approximately 1,340 acres; 13.67 acres of land; and approximately 440 acres of leased land in Lander County, Nevada. Pacific Gold also owns 16 placer claims covering approximately 320 acres in Josephine County, Oregon, which include the Bear Bench project and Defiance Mine. In addition, the company owns 36 claims covering 640 acres of the Lower Olinghouse Placers, known as Butcher Boy and Teddy located 34 miles east of Reno, Nevada. Further, it has rights to claims within Project W, a tungsten project covering approximately 600 acres in Mineral County, Nevada, as well as owns 24 unpatented lode mining claims in San Juan and Dolores Counties, Colorado. The company was incorporated as Demand Financial International, Ltd. in 1996 and changed its name to Blue Fish Entertainment, Inc. in 2002. Further, it changed its name to Pacific Gold Corp. in 2003. The company is based in Reno, Nevada.
PCFGD News:
January 18 - Pacific Gold Corp.: Reverse Stock Split and Amended Articles of Incorporation
Pacific Gold Corp. (OTCBB: PCFGD) (the "Company") announced that, effective upon market open on January 22, 2013, every twenty shares of the Company''s issued and outstanding Common Stock, par value $0.0000000001 (the "Common Stock"), will convert into one share of Common Stock (the "Reverse Stock Split"). Any fractional shares resulting from the Reverse Stock Split will be rounded up to the next whole share. As a result of the Reverse Stock Split, the total number of issued and outstanding shares of the Company''s Common Stock will decrease from 3,867,674,530 pre-split shares to approximately 193,383,727 shares after giving effect to the Reverse Stock Split.
In addition, as part of the Reverse Stock Split, the Company will also be reducing its total number of authorized shares of common stock from 5,000,000,000 to 3,000,000,000 as approved by the Company''s stockholders at last year''s Annual Meeting.
At the open of business on January 22, 2013 the common stock of the Company will trade under the symbol PCFGD for a period of 20 business days after which time the D will be removed from the stock symbol.
KERYX BIOPHARMACEUTICALS INCORPORATED (NASDAQ: KERX)
"Up 10.49% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/KERX.php
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease and cancer. Keryx is developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing KRX-0401 (perifosine), which is in Phase 3 clinical development for multiple myeloma. Keryx is headquartered in New York City.
KERX News:
January 28 - Keryx Biopharmaceuticals Announces Zerenex™ (ferric citrate) Meets Primary and All Key Secondary Endpoints in Phase 3 Long-Term Study as a Treatment for Hyperphosphatemia in End-Stage Renal Disease Patients on Dialysis
* Zerenex Significantly Increases Iron Storage Parameters and Decreases Need for Intravenous Iron and Erythropoiesis-Stimulating Agents Versus Active Control
U.S. and European New Drug Application Submissions Anticipated in Second Quarter 2013
* Conference Call to Be Held Today, Monday, January 28, 2013, at 8:00 am Eastern Time
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced successful top-line results from the long-term Phase 3 study of Zerenex™ (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate, for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. In this study, Zerenex met the study's primary endpoint, described below, demonstrating a highly statistically significant change in serum phosphorus versus placebo over the four-week Efficacy Assessment Period of the study. In addition, Zerenex met the key secondary endpoints of increasing ferritin and transferrin saturation (TSAT) and reducing the use of intravenous (IV) iron and erythropoiesis-stimulating agents (ESAs) versus the active control over the 52-week Safety Assessment Period of the study. This long-term study was the final component of the Company's Phase 3 registration program, which was conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). In April 2011, the Company reported the positive final dataset from the short-term study component of this Phase 3 registration program. The Company expects to submit a New Drug Application (NDA) with the FDA and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Zerenex in the second quarter of 2013.
Study Design
This Phase 3 long-term study was a multicenter, randomized, open-label, safety and efficacy clinical trial in 441 ESRD patients on hemodialysis or peritoneal dialysis. The study consisted of a 2-week washout period followed by a 52-week Safety Assessment Period in which subjects were randomized 2:1 to receive either Zerenex or an active control (Renvela® [sevelamer carbonate] and/or Phoslo® [calcium acetate]). The 52-week Safety Assessment Period was followed by a 4-week Efficacy Assessment Period. During the Efficacy Assessment Period, only those subjects randomized to treatment with Zerenex during the Safety Assessment Period were randomized in a 1:1 ratio to either continue treatment with Zerenex or switch to placebo for a 4-week treatment period. Subjects were titrated during the study to achieve serum phosphorus levels that ranged between 3.5 to 5.5 mg/dL.
The primary objectives of this study were to determine the long-term safety of KRX-0502 (ferric citrate) in subjects with ESRD undergoing either hemodialysis or peritoneal dialysis, and the efficacy of Zerenex following 52 weeks of treatment in a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period. Zerenex was administered using a 1 gram oral caplet formulation.
Oral iron therapy was not permitted during the course of the study. IV iron therapy was not permitted if a subject's serum ferritin level was greater than 1,000 ng/mL or the transferrin saturation (TSAT) was greater than 30%. The use of ESAs was at the physician's discretion.
Primary Efficacy Endpoint
The primary efficacy endpoint of this trial was the mean change in serum phosphorus from baseline (Week 52) to end of the four-week Efficacy Assessment Period (Week 56) versus placebo in the Intent-to-Treat (ITT) group. The ITT group included 183 subjects, representing all subjects who took at least one dose of Zerenex or placebo in the Efficacy Assessment Period and provided at least one post-baseline efficacy assessment.
Zerenex met the primary efficacy endpoint with a highly statistically significant result (p<0.0001). In addition, as agreed to with the European Medicines Agency (EMA), the treatment difference between Zerenex and Renvela® (sevelamer carbonate) at Week 12 of the Safety Assessment Period in terms of change from baseline (Day 0) in serum phosphorus was analyzed. Zerenex successfully achieved the non-inferiority endpoint versus Renvela®.
Key Secondary Efficacy Endpoints Related to Iron
The objectives of the key iron-related secondary endpoints, which were all pre-specified in the statistical analysis plan, were to corroborate prior data which suggested that Zerenex may increase iron storage parameters and reduce the need for IV iron and/or ESAs. Zerenex met all the key secondary efficacy endpoints related to iron with statistically significant treatment differences versus the active control group (Renvela® [sevelamer carbonate] and/or Phoslo® [calcium acetate]).
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